Gilead’s Seladelpar gets European Marketing Authorization for liver disease treatment
Gilead Sciences (GILD) said on Friday that the European Commission (EC) granted conditional marketing authorization for ...
NL Times7d
Russian spies had access to EMA systems for four months in 2020 hack: report
Russian attackers were behind the hack of the European Medicines Agency EMA in 2020. They had “unauthorized access to ...
Hosted on MSN7d
EU reshapes HTAs: is the industry ready for it?
New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.
EMA validates indication extension application for Aspaveli® for treatment of C3G and primary IC-MPGN
Sobi® and Apellis Pharmaceuticals today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli® (pegcetacoplan) for the treatment of C3 ...
Apellis and Sobi Announce EMA Validation of Indication Extension Application for Aspaveli® (pegcetacoplan) for C3G and Primary IC-MPGN
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi ® (STO:SOBI) today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli ® (pegcetacoplan) ...
C3i Center, a Canadian company, receives approval from the EMA to manufacture cell therapy products for the European market
C3i became the first contract development and manufacturing organization (CDMO) for cell and gene therapies in Canada to obtain a Drug Establishment License (DEL) to produce life-saving cell therapies ...
GEN2d
C3i Center Receives EMA Approval to Manufacture Cell Therapy Products for Europe
C3i obtained a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.
Medscape7d
EMA Launches Review of Finasteride for Suicidal Ideation
The European Medicines Agency has started a review of medicines containing finasteride and dutasteride following concerns ...
Managed Healthcare Executive1d
FDA, EMA See Differences in Cell and Gene Therapy Trial Data
Researchers have suggested that uniform evidence standards and reporting requirements could help speed patient access to cell ...
centerforbiosimilars3d
FDA, EMA Approve Second Pair of Denosumab Biosimilars
The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' ...
JD Supra13d
EU Biosimilar Regulatory and Launch Updates
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...
EURACTIV7d
Czechia wants clear definition of patient groups in new EU pharma law
Czechia proposes changes that will better define the role of patient organisations when informing patients about therapeutic procedures without violating advertising regulations.